1. Field of the Invention
The present invention relates to urinary incontinence in general, and more specifically to a male urinary incontinence device using a wrap for enveloping the penis.
2. Background
Urinary Incontinence (UI) is a very common problem in the United States estimated to afflict more than 13 million people. Of those afflicted, about one third are men. The total annual cost of providing care for persons with UI is estimated to be $16 billion. The market for adult absorbent devices or diapers alone in 1994 was $1.5 billion projected to be growing about 25% per year. As the demographics in the United States shift to a more aged population, and as society in general becomes increasingly mobile, the increasing number of persons suffering from, and demanding solutions for UI will simultaneously increase.
UI can affect persons of all ages, and may be the result of physical disability or a psychological condition. There are several different types of incontinence, which are outlined below.
Acute (or Transient) Incontinence is caused by generally treatable medical problems. Medical conditions such as dehydration, delirium, urinary retention, fecal impaction/constipation, urinary tract infection and atrophic vaginitis can cause an onset of UI. In addition to medical problems, certain medications can cause or contribute to an incontinence problem, such as anticholinergic agents, antihistamines, antidepressants (TCA), phenothiazines, disopyramides, opiates, antispasmodics, Parkinson drugs, alpha-adrenergic agents (high blood pressure drugs), sympathomimetics (decongestants), and sympatholytics (e.g., prazosin, terazosin, and doxazosin).
Chronic UI is by definition an ongoing and therefore more difficult to treat affliction. Chronic UI is conventionally classified into four groups: Stress, Urge, Overflow, and Functional incontinence. They may occur alone or in combination, the latter being more common as the patient ages.
Stress incontinence is the involuntary leakage of small amounts of urine in response to increased pressure in the abdomen. Incontinence will usually occur during physical events, such as sneezing, coughing, laughing, bending, lifting, etc. Although stress incontinence is predominantly a female affliction, men can also suffer from stress incontinence. Stress incontinence in men usually results from a weakened function of the urethral sphincter that surrounds the prostate, sometimes as a result of prostate surgery.
Urge incontinence is the most common pattern of UI in middle aged and older people, and is characterized by insufficient control during the time between the urge to void and the start of urination. One cause of urge UI is detrusor hyperreflexia or instability which is associated with disorders of the lower urinary tract or neurologic system. Urge incontinence can also be the result of urologic carcinoma, diverticula, or other physical abnormalities.
Overflow incontinence accounts for 10-15% of urinary incontinence. Overflow UI is usually the result of an obstruction. (e.g., enlarged prostate, urethral stricture) of the bladder outlet or an atonic bladder as the result of neurologic injury (e.g., spinal chord trauma, stroke), diabetic neuropathic bladder, or drug-induced atonia. The obstruction leads to bladder overfilling, resulting in a compulsive detrusor contraction. In this form of UI chronic "dribbling" is common. Drug induced atonia can be caused by anticholinergics, narcotics, anti-depressants, and smooth muscle relaxants.
Functional incontinence accounts for 25% of all incontinence and results when a person is confined and sedentary, such as in a nursing home or during a long period of convalescence. Functional incontinence is sometimes diagnosed as a result of the individual simply being unable to communicate his or her needs, or through other sensory impairments that make the individual unaware of his or her need to void. This condition can further result from decreased mental function, decreased functional status, and/or a simple unwillingness to physically go to the toilet.
Incontinence is also frequent among persons rehabilitating from stroke, head injury, multiple sclerosis, amputations, and spinal cord injury.
Enuresis, or bedwetting, is a form of incontinence that is very common among preschool children, and often persists into adulthood. Enuresis can cause degraded self-esteem, and may lead to social withdrawal at an early age. The bedwetter may be reluctant to attend sleep over social events with his or her friends. Most often, the reason a child or adult will have the problem of nocturnal enuresis is because they simply cannot wake up. Nocturnal enuresis afflicts approximately 15-20% of school age children between the ages of 4 and 16. Treatment of enuresis typically requires training the person to recognize the need to urinate during sleep, or to train the person to sleep correctly. Moisture sensing alarms have been successfully employed, but if soiled bedding are to be avoided, require the use of diapers or other absorbent padding.
Some symptoms of UI that interfere with quality of life include leaking urine when coughing, sneezing, laughing or exercising; waking up multiple times at night to go to the bathroom; the need to know the locations of bathrooms when on travel or shopping; and the leaking of urine during sex. UI can obviously lead to discomfort and embarrassment, and eventually to social withdrawal and isolation. Excursions outside the home, social interaction, and sexual activity may be restricted or avoided entirely in the presence of incontinence. In older persons, UI is the predominant reason aging parents are put into nursing homes, because of the burden UI places on caregivers.
Means for aiding incontinence in the prior art include catheterization, absorbent products, and for males, devices attached to the exterior surface of the penis to collect urine discharge. For children prone to bedwetting, various approaches are also available, for example wet-bed alarm systems, which are readily available and easy to use, and Desmopressin acetate (synthetic ADH), a nasal spray.
Catheterization is an unattractive option to many persons suffering from UI because of the risks associated with an indwelling catheter. The catheter may be retained permanently in the bladder draining freely into a collection bag. In the permanent arrangement, the catheter is held in the bladder by a balloon, usually inflated with sterile water. The catheter may also be inserted intermittently on an as-needed basis. This approach is very inconvenient and many patients are psychologically averse to self-catheterization, or physically unable to perform the manipulations required.
Long term use of indwelling catheters presents further problems. Within 2 to 4 weeks after permanent catheterization, the urine of virtually every patient is contaminated by bacteria. Catheter-associated bacteriuria represents the most common infection acquired in acute care and long-term care facilities. Complications ranging from bladder spasms and catheter leakage to death caused by septicemia are also well known limitations. Bacterial entry into the bladder occurs either from extraluminal migration along the outside of the catheter, contamination on insertion of the catheter, or contamination of the drainage bag, leading to bacterial growth and subsequent migration into the bladder.
Accordingly, catheterization is overall the least preferred type of bladder management.
Absorbent devices, such as diapers, are the most popular remedy, accounting for billions of dollars in annual sales in the US. They are easily obtained, and can address acute UI symptoms quickly. While affording somewhat effective control of urine and providing mobility to the patient, the absorbent method suffers from very serious drawbacks.
First, absorbent devices do not remove urine to a point distal from the genital region, they simply absorb and disperse the urine in order to manage it. This, of course, leads to urine soaked absorbent being in contact with the skin, which causes irritation and discomfort. Most advances in the art deal with providing different absorbent layers to attempt to direct the urine to migrate to a region away from the skin, with limited success.
Absorbent devices also disadvantageously rely on providing a large area of absorbent, usually in the form of pants or diapers. Not only is such an arrangement uncomfortable, it requires involved procedures for applying and removing the device. Further, the diaper pants must be removed in order to defecate, apply medications to the groin area, etc. Once removed, whether soiled or not, the disposable-type diaper usually must be disposed of, creating the need to always carry a supply of such absorbent devices.
A major problem with absorbent devices is that of odor. Urine has a distinctive and recognizable odor which is embarrassing to most people. Various approaches have been taken in order to control urine odor with absorbent devices, with limited success.
In men, an alternative to the indwelling catheter or absorbent device is an external collecting device which is fitted over the male genitalia, like a condom, and connected via a tube to a drainage bag held onto the body by leg straps, or by special devices like the one leg pant marketed by NETTI.RTM., as well as bedside drainage bags which are available while one in bed. Several such "external catheter" devices are described in the prior art.
U.S. Pat. Nos. 5,797,890 and 5,009,649 describe male UI condom catheters. In these type devices, a latex or similar material condom is unrolled onto the penis, sealingly engaging the same. An extended fluid collection region extending from the distal end of the device provides a reservoir for collected urine. The condom is additionally held to the penis by means of a band, for example using VELCRO.RTM.. The '890 patent additionally provides a ring mounted on a simple garment support that allows the rolled, proximal end of the condom to be unrolled about the ring, allowing additional support of the device, but requiring that the frequently flaccid penis be inserted under axial load into the condom.
These devices are disadvantaged by the complexity of their application, and the requirement that the condoms be properly sized for the device to function properly. The application of the condom member requires some degree of dexterity to position and unroll the condom onto the penis, which is frequently flaccid. The flaccid state of the penis renders the seal created by the condom variably effective, and frequently inadequate. Further, in the case of a patient deprived of the full use of his motor skills, for example a stroke patient or MS sufferer, the task may be impossible. Frequently, the issue of condom sizing creates difficulties, when the purchaser is other than the user, or when the user is less than sure about his relative girth.
A further severe disadvantage with this type of device is that should the evacuation tube at the distal end of the condom become kinked or blocked, urine pressure will build in the condom until urine is forcefully ejected along the side of the condom, the condom breaks, or the entire apparatus slips from the penis. The spread of urine up the shaft of the penis lowers the friction between the condom and the penile shaft, increasing the chances of the penis slipping from the condom. Such events can be extremely messy, causing the forceful discharge of a substantial amount of urine into the pants of the wearer.
Other devices comprise a loose-fitting sleeve for the penis, such as the McGuire style mail urinal. The urinal, which is in effect a bag into which the penis extends, is used in conjunction with a valved tube leading to a leg bag. In theory, the urinal drains into the leg bag. These devices create serious problems with poor sealing and spillage of urine around the penis, and even present the problem of a flaccid and withdrawn penis pulling out of the sleeve altogether. Because the device relies on gravity to feed urine from the urinal to the leg bag, use during sitting can be messy or uncomfortable.
Improvements to the prior art are continually being sought.